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510(k) K821700

LATEX PENROSE DRAIN TUBING by Abco Dealers, Inc. — Product Code GAX

K821700 is an FDA 510(k) premarket notification submitted by Abco Dealers, Inc. for the device "LATEX PENROSE DRAIN TUBING". The FDA issued a decision of Substantially Equivalent on June 16, 1982. The device falls under product code GAX (Tourniquet, Nonpneumatic), a Class I device regulated under 21 CFR 878.5900. Abco Dealers, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1982
Date Received
June 8, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tourniquet, Nonpneumatic
Device Class
Class I
Regulation Number
878.5900
Review Panel
SU
Submission Type

Other clearances by Abco Dealers, Inc.

  • K905025 — DIGITAL THERMOMETER KITS (February 7, 1991)
  • K882304 — DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL) (July 12, 1988)
  • K880892 — BLOOD COLLECTING NEEDLE AND HOLDERS (April 21, 1988)
  • K880894 — ALLERGIST SYRINGES (March 31, 1988)
  • K872875 — STRETCH GAUZE BANDAGES (September 4, 1987)
  • K872874 — MICROSCOPE COVER GLASSES (August 10, 1987)
  • K872797 — NON-SKID SHOE COVERS (August 4, 1987)
  • K871465 — THERMOMETER SHEATHS (May 11, 1987)
  • K862726 — DISPOSABLE SHOE COVERS AND NURSES CAPS (August 1, 1986)
  • K862111 — ARMBOARDS, REUSABLE AND DISPOSABLE (July 8, 1986)

Other clearances for product code GAX

  • K931198 — UNIQUET (September 1, 1993)
  • K881398 — TOURNIQUET (April 29, 1988)
  • K881176 — STERILE ESMARCH BANDAGE (April 11, 1988)
  • K875092 — DEGANIA SILICONE TOURNIQUET (January 7, 1988)
  • K873928 — UNIVERSAL TOURNIQUET (October 23, 1987)
  • K872003 — KINDERWRAP (June 23, 1987)
  • K864897 — DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335 (January 12, 1987)
  • K853472 — FINGER TOURNIQUETTE (October 10, 1985)
  • K853537 — VELCRO TOURNIQUET (September 12, 1985)
  • K852277 — CATAPRESS TOURNIGUET (June 27, 1985)

FDA data resources